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Completed

NCT Number: NCT02690337

Study of DS-1123a in Advanced Solid Tumours

This is an open-label study to evaluate the safety, tolerability, and pharmacokinetics of DS-1123a in Japanese subjects with advanced solid tumors.

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Key information

Conditions

Advanced Solid Malignant Tumors Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Tokyo, 277-8577, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Advanced solid tumor that is refractory to standard treatment, or for which no standard treatment is available.
  • Eastern Cooperative Oncology Group performance status (PS) of 0 or 1.

Exclusion criteria

  • Have any of the following concomitant disease or had the history of having following disease within 6 months before enrollment:
  • Cardiac failure (NYHA ≥ ClassIII), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary-artery/peripheral artery bypass surgery, cerebrovascular disease, pulmonary thromboembolism, deep-vein thrombosis or clinically severe thromboembolic event, or clinically severe pulmonary disease (eg, interstitial pneumonia, pulmonary fibrosis, radiation pneumonia, drug induced pneumonia),
  • Severe or uncontrolled concomitant disease.
  • Clinically active brain metastases defined as symptomatic or requiring treatment.

Treatment and study plan

DS-1123

Drug

starting intravenous (IV) dose of 0.1 mg/kg.

Primary outcomes

  1. Maximum concentration (Cmax)

    Time frame: Cycles 1, 2 : Days 1,2, 4, 8, 15

  2. Number and severity of treatment emergent adverse events (TEAEs)

    Time frame: Day 1 to Day 31

  3. Time of maximum concentration (Tmax)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  4. Elimination rate constant (Kel)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  5. area under the curve AUClast

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

    pharmacokinetics profile

  6. Area under the curve (AUCtau)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  7. Area under the curve (AUCinf)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  8. Half-life (T1/2)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  9. Drug clearance (CL)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  10. Volume of distribution (Vz)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

  11. Mean residence time (MRTinf)

    Time frame: Cycles 1, 2: Days 1,2, 4, 8, 15

Secondary outcomes

  1. DS-1123a antibody

    Time frame: Cycle 1: Days 1,15; Cycles 2: Day 1; Stop date, final follow-up date

    DS-1123a antibody on Cycle 1: Days 1,15; Cycles 2 and on: Day 1, Stop date, final follow-up date

  2. Change in Cytokines expression

    Time frame: Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2

    Change in DS-1123a biomarkers Cytokines expression on Cycle 1: Days 1, 2, 15, 16; Cycle 2: Days 1, 2

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo Co., Ltd.

Industry

Registry information

Official study title

Phase 1, Open-label Study to Assess the Safety, Tolerability, and Pharmacokinetics of DS-1123a in Subjects With Advanced Solid Tumors

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 24, 2016
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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